Drug
Decitabine
Important: Reactions below are the flagged terms from this drug’s
FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate
disproportionality in spontaneous reporting, not causation.
Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.
| Reaction | Co-reports (a) | PRR | ROR | Signal | |
|---|---|---|---|---|---|
| 1 | Acute Myeloid Leukaemia | 240 | 77.3 | 81.9 | signal |
| 2 | Myelosuppression | 372 | 54.6 | 59.8 | signal |
| 3 | Febrile Neutropenia | 455 | 34.2 | 38.2 | signal |
| 4 | Myelodysplastic Syndrome | 88 | 30.2 | 30.8 | signal |
| 5 | Haematotoxicity | 54 | 28.9 | 29.3 | signal |
| 6 | Cytopenia | 67 | 27.9 | 28.3 | signal |
| 7 | Bone Marrow Failure | 110 | 26.7 | 27.4 | signal |
| 8 | Bacteraemia | 62 | 26.2 | 26.5 | signal |
| 9 | Therapy Partial Responder | 48 | 15.8 | 16.0 | signal |
| 10 | Hyperbilirubinaemia | 31 | 14.9 | 15.0 | signal |
| 11 | Pancytopenia | 154 | 13.7 | 14.2 | signal |
| 12 | Mucosal Inflammation | 72 | 13.7 | 13.9 | signal |
| 13 | Lung Infection | 42 | 13.2 | 13.3 | signal |
| 14 | Hospice Care | 25 | 12.6 | 12.6 | signal |
| 15 | Posterior Reversible Encephalopathy Syndrome | 24 | 12.5 | 12.6 | signal |
| 16 | Thrombocytopenia | 240 | 10.7 | 11.2 | signal |
| 17 | Neutropenia | 287 | 10.5 | 11.2 | signal |
| 18 | Therapy Non-responder | 92 | 10.2 | 10.4 | signal |
| 19 | Septic Shock | 86 | 9.8 | 10.0 | signal |
| 20 | Clostridium Difficile Colitis | 21 | 9.8 | 9.8 | signal |
| 21 | Sepsis | 206 | 9.1 | 9.6 | signal |
| 22 | Haemorrhage Intracranial | 26 | 8.6 | 8.6 | signal |
| 23 | Neutrophil Count Decreased | 66 | 8.1 | 8.2 | signal |
| 24 | Respiratory Failure | 117 | 7.9 | 8.1 | signal |
| 25 | Disease Progression | 189 | 7.9 | 8.3 | signal |
| 26 | Bacterial Infection | 29 | 7.7 | 7.8 | signal |
| 27 | Skin Infection | 17 | 7.5 | 7.6 | signal |
| 28 | Leukocytosis | 27 | 7.4 | 7.4 | signal |
| 29 | Leukaemia | 14 | 7.3 | 7.4 | signal |
| 30 | Agranulocytosis | 27 | 7.2 | 7.3 | signal |
| 31 | Platelet Count Decreased | 154 | 7.2 | 7.4 | signal |
| 32 | Transfusion | 15 | 7.1 | 7.1 | signal |
| 33 | Cardiomyopathy | 21 | 7.0 | 7.1 | signal |
| 34 | Acute Respiratory Failure | 27 | 7.0 | 7.0 | signal |
| 35 | Drug Resistance | 36 | 6.9 | 7.0 | signal |
| 36 | Blood Count Abnormal | 21 | 6.8 | 6.8 | signal |
| 37 | Thrombotic Microangiopathy | 13 | 6.6 | 6.7 | signal |
| 38 | Gingival Bleeding | 18 | 6.5 | 6.5 | signal |
| 39 | Infection | 178 | 6.1 | 6.3 | signal |
| 40 | Multiple Organ Dysfunction Syndrome | 34 | 6.0 | 6.1 | signal |
| 41 | Full Blood Count Decreased | 24 | 5.9 | 5.9 | signal |
| 42 | White Blood Cell Count Decreased | 128 | 5.8 | 6.0 | signal |
| 43 | Device Related Infection | 18 | 5.8 | 5.8 | signal |
| 44 | Disseminated Intravascular Coagulation | 16 | 5.6 | 5.6 | signal |
| 45 | Fungal Infection | 37 | 5.5 | 5.5 | signal |
| 46 | Splenomegaly | 13 | 5.5 | 5.5 | signal |
| 47 | Red Blood Cell Count Decreased | 31 | 5.4 | 5.4 | signal |
| 48 | Pneumonitis | 29 | 5.3 | 5.3 | signal |
| 49 | Petechiae | 11 | 5.2 | 5.2 | signal |
| 50 | Ileus | 13 | 5.2 | 5.2 | signal |
| 51 | Hypoxia | 36 | 5.1 | 5.1 | signal |
| 52 | Neoplasm Progression | 36 | 5.1 | 5.1 | signal |
| 53 | Pneumonia | 319 | 4.9 | 5.2 | signal |
| 54 | Tooth Abscess | 10 | 4.8 | 4.8 | signal |
| 55 | Drug Ineffective For Unapproved Indication | 54 | 4.8 | 4.8 | signal |
| 56 | Ventricular Tachycardia | 16 | 4.8 | 4.8 | signal |
| 57 | Acute Respiratory Distress Syndrome | 17 | 4.8 | 4.8 | signal |
| 58 | Blood Bilirubin Increased | 26 | 4.7 | 4.8 | signal |
| 59 | Disease Recurrence | 45 | 4.7 | 4.7 | signal |
| 60 | Haemoglobin Decreased | 97 | 4.7 | 4.7 | signal |
| 61 | Supraventricular Tachycardia | 9 | 4.7 | 4.7 | signal |
| 62 | Liver Injury | 22 | 4.5 | 4.5 | signal |
| 63 | Hypophagia | 23 | 4.5 | 4.5 | signal |
| 64 | Candida Infection | 15 | 4.4 | 4.5 | signal |
| 65 | Product Use In Unapproved Indication | 218 | 4.4 | 4.6 | signal |
| 66 | Anaemia | 167 | 4.3 | 4.5 | signal |
| 67 | Cardiac Failure | 70 | 4.3 | 4.4 | signal |
| 68 | Electrolyte Imbalance | 10 | 4.3 | 4.3 | signal |
| 69 | Hypomagnesaemia | 12 | 4.3 | 4.3 | signal |
| 70 | Blood Test Abnormal | 12 | 4.2 | 4.2 | signal |
| 71 | Subdural Haematoma | 12 | 4.1 | 4.1 | signal |
| 72 | Colitis | 31 | 4.1 | 4.1 | signal |
| 73 | Hypocalcaemia | 15 | 3.9 | 3.9 | signal |
| 74 | Lymphocyte Count Decreased | 14 | 3.9 | 3.9 | signal |
| 75 | Leukopenia | 39 | 3.9 | 3.9 | signal |
| 76 | Body Temperature Increased | 16 | 3.9 | 3.9 | signal |
| 77 | Drug-induced Liver Injury | 24 | 3.8 | 3.9 | signal |
| 78 | Platelet Count Increased | 10 | 3.8 | 3.8 | signal |
| 79 | Mouth Ulceration | 16 | 3.8 | 3.8 | signal |
| 80 | Malignant Neoplasm Progression | 77 | 3.7 | 3.8 | signal |
| 81 | Staphylococcal Infection | 25 | 3.7 | 3.7 | signal |
| 82 | Appendicitis | 7 | 3.7 | 3.7 | signal |
| 83 | Pyrexia | 260 | 3.7 | 3.9 | signal |
| 84 | Immunodeficiency | 11 | 3.7 | 3.7 | signal |
| 85 | Gastrointestinal Haemorrhage | 61 | 3.6 | 3.6 | signal |
| 86 | Pneumocystis Jirovecii Pneumonia | 7 | 3.5 | 3.5 | signal |
| 87 | Cytokine Release Syndrome | 13 | 3.4 | 3.4 | signal |
| 88 | Hepatic Function Abnormal | 25 | 3.3 | 3.3 | signal |
| 89 | Pleural Effusion | 41 | 3.3 | 3.3 | signal |
| 90 | Pulmonary Oedema | 30 | 3.3 | 3.3 | signal |
| 91 | Haematocrit Decreased | 13 | 3.2 | 3.2 | signal |
| 92 | Mental Status Changes | 18 | 3.2 | 3.2 | signal |
| 93 | No Therapeutic Response | 8 | 3.2 | 3.2 | signal |
| 94 | Blood Alkaline Phosphatase Increased | 16 | 3.2 | 3.2 | signal |
| 95 | Sinus Tachycardia | 9 | 3.1 | 3.1 | signal |
| 96 | Melaena | 14 | 3.1 | 3.1 | signal |
| 97 | Hepatotoxicity | 14 | 3.1 | 3.1 | signal |
| 98 | Haemorrhoids | 12 | 3.0 | 3.0 | signal |
| 99 | Renal Tubular Necrosis | 6 | 3.0 | 3.0 | signal |
| 100 | Pericarditis | 10 | 3.0 | 3.0 | signal |
| 101 | Palmar-plantar Erythrodysaesthesia Syndrome | 14 | 3.0 | 3.0 | signal |
| 102 | Alanine Aminotransferase Increased | 36 | 2.9 | 2.9 | signal |
| 103 | Off Label Use | 501 | 2.9 | 3.1 | signal |
| 104 | Multi-organ Failure | 10 | 2.8 | 2.8 | signal |
| 105 | Blood Lactate Dehydrogenase Increased | 9 | 2.8 | 2.8 | signal |
| 106 | Tooth Extraction | 7 | 2.8 | 2.8 | signal |
| 107 | Cellulitis | 28 | 2.7 | 2.8 | signal |
| 108 | Clostridium Difficile Infection | 12 | 2.7 | 2.7 | signal |
| 109 | White Blood Cell Count Increased | 21 | 2.7 | 2.7 | signal |
| 110 | Cytomegalovirus Infection | 9 | 2.7 | 2.7 | signal |
| 111 | Tooth Infection | 7 | 2.6 | 2.6 | signal |
| 112 | Myocarditis | 6 | 2.6 | 2.6 | signal |
| 113 | Atrial Fibrillation | 50 | 2.5 | 2.6 | signal |
| 114 | Acute Myocardial Infarction | 15 | 2.5 | 2.5 | signal |
| 115 | Pericardial Effusion | 11 | 2.4 | 2.4 | signal |
| 116 | Fluid Overload | 7 | 2.3 | 2.3 | signal |
| 117 | Full Blood Count Abnormal | 5 | 2.3 | 2.3 | no signal |
| 118 | Diverticulitis | 13 | 2.3 | 2.3 | signal |
| 119 | Renal Failure Acute | 20 | 2.3 | 2.3 | signal |
| 120 | Orthostatic Hypotension | 8 | 2.3 | 2.3 | signal |
| 121 | Treatment Failure | 37 | 2.2 | 2.2 | signal |
| 122 | Therapeutic Response Decreased | 27 | 2.2 | 2.2 | signal |
| 123 | Hepatic Failure | 13 | 2.1 | 2.1 | signal |
| 124 | Vasculitis | 5 | 2.1 | 2.1 | no signal |
| 125 | Haematoma | 11 | 2.1 | 2.1 | signal |
| 126 | Bronchospasm | 6 | 2.1 | 2.1 | no signal |
| 127 | Diabetic Ketoacidosis | 10 | 2.1 | 2.1 | signal |
| 128 | Interstitial Lung Disease | 19 | 1.9 | 1.9 | no signal |
| 129 | Subarachnoid Haemorrhage | 4 | 1.9 | 1.9 | no signal |
| 130 | Abscess | 6 | 1.9 | 1.9 | no signal |
| 131 | Haemorrhage | 35 | 1.7 | 1.7 | no signal |
| 132 | Death | 285 | 1.6 | 1.7 | no signal |
| 133 | Osteonecrosis Of Jaw | 8 | 1.6 | 1.6 | no signal |
| 134 | Mydriasis | 4 | 1.5 | 1.5 | no signal |
| 135 | Neurotoxicity | 5 | 1.4 | 1.4 | no signal |
| 136 | Lactic Acidosis | 9 | 1.4 | 1.4 | no signal |
| 137 | Fistula | 3 | 1.3 | 1.3 | no signal |
| 138 | Circumstance Or Information Capable Of Leading To Medication Error | 7 | 1.0 | 1.0 | no signal |
| 139 | Drug Effective For Unapproved Indication | 6 | 1.0 | 1.0 | no signal |
| 140 | Product Storage Error | 10 | 0.6 | 0.6 | no signal |